Clinical Data Management

From clinical database design and setup through cleaning and reporting to database lock, Allucent’s clinical data management experts deliver timely and quality clinical data by using the latest technologies, robust processes, and regulatory-compliant clinical data management tools. We apply standardized, established, compliant processes from electronic case report form (eCRF) design to the delivery of final datasets using CDISC standards. We are experts in the development of therapeutic area–specific eCRFs and can manage studies efficiently in any therapeutic indication, specializing in designing and executing studies in complex trial designs. Our team will guide you through the process, provide advice, and ensure that the data meets the highest quality standards. We facilitate efficient study start-up and execution while remaining focused on addressing and mitigating risks, challenges, and complexities for each project.

Our dedicated project team works with you to develop optimal strategies and deliver fit-for-purpose, tailor-made deliverables. We pride ourselves in an open and transparent approach where communication, accountability, and ownership are key. Working with our A-team, you can expect a lean management approach to accomplish operational excellence while controlling costs, supported by strong oversight and hands-on involvement of senior leaders. We understand the importance of staying flexible while achieving project timelines and quality results. With worldwide coverage and experienced local resources, we offer an ideal blend of global capabilities and a personal, proactive, pragmatic approach.

Allucent’s global clinical data management team is a group of professionals with more than 20 years of experience in the industry, providing best-in-class services. Our goal is to promote high-quality, meaningful data and maintain standards and good practices, using the latest technology and complaint data management tools. We have experience with a range of electronic data capture (EDC) systems.

Clinical Data Management Services 

Allucent CRO offers clinical data management services encompassing design, setup, and full conduct to closure, working collaboratively within established cross-functional workflows with internal colleagues in other biometrics disciplines. This ensures a seamless transition from data management to clinical programming and reporting and analytics. We offer a flexible and tailor-made approach to the specific needs of your project, either as a full-service solution or by providing stand-alone in-house services. 

Our clinical data management services include:

  • Project data management, planning, and documentation
  • Development of clinical data management and data validation plans
  • EDC database build and validation (CDASH/SDTM compliant)
  • Edit check programming, testing, and validation
  • Clinical data validation and data quality review for inconsistencies, trends, and outliers
  • Medical coding (MedDRA and WHODrug)
  • SAE reconciliation
  • Planning and management of third-party data
  • Production and review of real-time EDC metric reports
  • Electronic patient-reported outcome (ePRO) setup
  • IWRS setup and maintenance including randomization, drug dispensing and inventory management
  • Clinical data insights and analytics
  • Risk-based monitoring support 
  • DCT support